Archive for the ‘Oncology’ Category

Leading up to the second Turning the Tide Against Cancer Through Sustain Medical Innovation national conference on October 9, 2014, in Washington, D.C., the Age of Personalized Medicine editorial team had the chance to sit down with leaders from the initiative’s co-convening organizations to talk about the current cancer research and care landscape, what progress has been made since the start of the initiative, and the upcoming conference.

Our conversation with Marcia A. Kean, M.B.A., chairman of Feinstein Kean Healthcare, on the importance of enacting policies that keep pace with the rapid development of innovative cancer treatments, can be viewed below. Stay tuned for our video interview with Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the American Association for Cancer Research.

This year’s conference will bring together leaders from across the cancer community to help identify specific policy solutions to the challenges of supporting the shift to patient-centered research and care and addressing the value and cost of cancer care — two key themes that have emerged through the initiative’s ongoing work.

The Age of Personalized Medicine editorial team sat down with each of the initiative co-conveners to talk about the current cancer research and care landscape, the upcoming conference, and what progress has been made since the start of the Turning the Tide Against Cancer initiative in 2011.

Our conversation with Edward Abrahams Ph.D., president of the Personalized Medicine Coalition can be viewed below. Stay tuned for additional video interviews with Margaret Foti, Ph.D., M.D. (h.c.), chief executive officer of the American Association for Cancer Research and Marcia A. Kean, M.B.A., chairman of Feinstein Kean Healthcare.

Visit the Turning the Tide Against Cancer website to register for the conference and learn more about ways you or your organization can support the ongoing initiative. The Age of Personalized Medicine will also be tweeting live from the conference on October 9.

Recent advances in cancer research have expanded our understanding of how cancer develops, and how to target treatments for specific cancer types. However, cancer – a collective term to describe more than 200 unique diseases – remains the second most common cause of disease-related death in the United States according to the AACR Cancer Progress Report 2013.

The American Association for Cancer Research (AACR) supports the need for ongoing research and the translation of scientific discoveries into new and better ways to prevent, detect, diagnose and treat cancer. To that end, along with the Personalized Medicine Coalition (PMC) and Feinstein Kean Healthcare (FKH), the Turning the Tide Against Cancer national conference was convened in 2012.

As members across all stakeholder groups joined together to consider the status and future of innovation in cancer research and care, it became clear that an ongoing discussion was needed to sustain progress against cancer. Today, the conference has evolved into an initiative to unite stakeholders within the cancer community to identify specific policy proposals policies that align with emerging science and evolving perceptions of value.

The report also points out that while we have a greater ability to collect and analyze scientific information than at any other point in medical history, a deluge of data alone will not answer the basic question of how value is defined. I encourage you to review the article to learn more about the challenges of defining value in a field where patient experiences and expectations can vary widely based on their clinical and life circumstances and personal preferences.

To address some of these challenges, the authors have identified policy suggestions that move towards better alignment with patient needs and values, and also consider the way science and clinical practice evolves over time, including incentivizing patient-centered research and care, and promoting a learning health care system. These are not prescriptive, but rather are a call for further discussion and community action. This fall, AACR, PMC and FKH will convene a national conference in Washington, D.C., to explore specific policy solutions that have emerged from our continued work. These policy solutions seek to foster continued innovation in cancer research and care so that improved outcomes for patients are delivered. Please stay tuned for additional information in the coming weeks.

When I received the invitation to speak at the Personalized Medicine World Conference (PWMC), I was excited. When I saw the program and faculty, I was honored. When I received my “assignment,” I was intimidated. To share the podium with many of the luminaries in the field of genomics — even to hear them speak — is tremendously exciting. In contrast, how can they really be interested in hearing me speak on the real-world challenges providers and payers face in bringing genomics advances from bench to bedside more quickly? I cannot answer this question. Although based solely on the number of conferences to which I am invited on this topic, someone must care. They should. Making the science “work” is only the first step in moving from bench to bedside.

As I was preparing my talk, I reflected on the story Sid Mukherjee, M.D., Ph.D., tells in his fabulous book, The Emperor of All Maladies: A Biography of Cancer. I’m not usually a big non-fiction fan, but if you are involved in cancer care in any way, this is a must read. Perhaps the book resonated because my professional career spanned many of the seminal events described in the book. That, and I share Dr. Mukherjee’s general perspective on the challenges of making meaningful advances in cancer treatment. The bottom line: cancer is tough. Just when we think we’ve made some great progress, it teaches us humility. Still, it is impossible not to be excited and enthusiastic about how far we have come in our understanding of the genetics of cancer. I really think we are experiencing a sea change. We must begin to think about navigating these changing currents in the world of health care reform in order to take best advantage of that progress.

So what are the practical challenges? There are many. And many share the underlying theme that the old paradigms do not work so well. Traditional methods of quality control in test performance, i.e. analytical validity, are a big problem. Proficiency testing and standards do not currently exist. To be honest, most doctors do not think about them when ordering a test. The billing and coding of molecular tests have been undergoing dramatic evolution but is still not suited to multi-analyte assays. Perhaps the biggest challenges lie in the area of clinical utility, which impacts providers, payers and regulatory agencies. Patients are impacted in a huge way. Most people have an idea of where we need to go, but we have a shortage of ideas about how to get there. Finally, all of this occurs in the setting of unsustainable growth in health care spending, and the near uniform agreement that we need to spend our money in a more intelligent, impactful way.

We have a lot of work to do together. It is important to remember we are all on the same side. We have a chance to make a huge difference, but we need to do it right.

What do you think our greatest challenges and opportunities are today? I look forward to the discussion in California.

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Ten years ago, the sequencing of the entire human genome, along with the development of aggregate “omics” technologies began giving rise to a fundamentally new capability for the practice of medicine – the ability to predict and track disease risks on a personalized basis, to understand diseases mechanistically, and to target therapy to treat an individual’s specific disease.

Based on the potential impact of these technologies, I predicted in my 2002 Chairman’s address to the Association of American Medical Colleges, that medicine would be transformed from being disease-focused and reactive to being proactive and personalized. I believed that the “one-size-fits-all” approach to disease care was outmoded and would soon be replaced by one that would prevent and treat disease on a personalized basis.

Since its inception ten years ago, many of those predictions have been realized; personalized medicine has begun to have major impacts on components of medical practice and has engendered health care industries estimated to grow to $450 billion by 2015 with $42 billion related to drugs, devices, and diagnostics. Molecular diagnostics have gained traction in cardiology, rheumatology, transplantation, endocrinology, and, in particular, oncology. Targeted therapies have revolutionized cancer therapy and whole genome sequencing is providing insights into baseline health risks and understanding of some diseases. However, while the use of personalized medicine tools to treat disease is gaining traction, the transformation of medical practice to being proactive, strategic, and personalized; i.e., personalized health care, has been slow to develop.

There is, however, evidence that this movement is gaining momentum and with increases in health care consumerism, a more predictable regulatory environment, and changes in medical reimbursement to reward better outcomes, the adoption of personalized health care is inevitable. Personalized medicine will go beyond the use of technologies to individualize disease care to finally transforming the approach to care itself by enabling individuals and care providers to foster proactive, personalized care. In turn, the clinical adoption of proactive, personalized care will broaden the need for personalized medicine technologies thus spurring the growth of this industry.

Appreciating the value of a ten-year review of personalized medicine, the Personalized Medicine World Conference will host, and I will moderate, a panel discussion titled, “Ten Years into Personalized Medicine: What We’ve Learned & What’s Next” on January 27, 2014 in Mountain View, Calif., with luminaries including Kim Popovits of Genomic Health, Randy Scott from InVitae, Brook Byers of KPCB, and Jay Flatley from Illumina, opining on what they initially anticipated, what they’ve learned, and what’s coming next.

It was great to see Angelina Jolie’s eloquent op-ed in the May 14 edition of The New York Times. She carefully wove her personal experience with the importance of genetic testing and using the resulting information to make an informed health decision. I applaud her decision to go public with her story as a great example of patient empowerment but also as a powerful example of personalized medicine in action.

Despite all the advances we have made in recent years, we all know that the concept of personalized medicine is still foreign to most Americans. PMC recently conducted focus groups which strongly reminded us of the uphill battle that remains to gain public understanding of and support for personalized medicine. In our groups only one or two out of 52 participants were able to correctly describe the concept.

We found that people are very enthusiastic about personalized medicine once they understand it but it is a complex concept which is often misunderstood. It turns out that giving clear, specific examples of personalized diagnostics and treatments is the best way to explain what personalized medicine is and the benefits it can bring.

Ms. Jolie’s contribution demonstrates that without patients who are educated, empowered to get tested and to act, the progress and innovation could be for naught. We need to make sure that patients are knowledgeable enough to pursue personalized options for their own health but also so that they are motivated to support policies that foster continued progress in this area.

Angelina Jolie’s op-ed is an important and high-profile contribution to the discourse about patient experience and personalized medicine. Her voice echoes the words of Adriana Jenkins, who courageously shared her battle against breast cancer and joins other advocates like Donna Cryer, who works tirelessly to remind all stakeholders about how personalize medicine is a patient-centric approach to healthcare. Courageous individuals, like Ms. Jolie, who publicly share their personal stories have the power to bolster both public and media discourse around patient empowerment, for example with CNN “Early Start” co-anchor Zoraida Sambolin’s disclosure of her own breast cancer diagnosis and treatment decision live on air.

I hope that Ms. Jolie’s op-ed raises awareness of personalized medicine and the options patients have to take control of their healthcare. No single organization alone can raise public awareness on the scale that we need but through a steady stream of individual op-eds, blog posts, conversations, etc., we in the personalized medicine community can spotlight more stories like this and begin to educate the public. I look forward to hearing more voices from the community and hope that their contributions will support personalized medicine research, patient and provider engagement, and thoughtful policy.

Ezekiel J. Emanuel’s “A Plan to Fix Cancer Care” (The New York Times, Op-Ed, March 23, 2013) highlights the need for collaboration and commitment across the oncology community to find solutions for the financial burden cancer poses to our healthcare system.

In order to sustain progress while containing cost, though, we must recognize the heterogeneity of the dreaded disease by eschewing a one-size-fits-all approach. We must, in short, devise strategies that make medical sense. These strategies necessarily will involve adaptive clinical trials, an intelligent regulatory policy that encourages linking therapy and diagnosis, and a willingness to pay for products that improve patient care.

Progress is driven by a dynamic process in which the full value of intervention evolves over time. We must be careful not to stifle innovation by overlooking the critical steps that can provide an answer to the correct question, which is: how can we maximize value from our growing, but not always wise, investments in health care?

Over a century ago Sir William Osler, M.D., stated: “Variability is the law of life and as no two faces are the same, so no two bodies are alike and no two individuals react alike and behave alike under the abnormal conditions which we know as disease.” Despite our deep and long-standing understanding of the heterogeneity of disease and the variations in response to treatment, we are slow to adopt the notion that despite its complexity, the heterogeneity of human illness is decipherable. Skepticisms that we can actually deliver on the promise of personalized medicine is understandable, since converting such variables as severity of illness, uncertain vulnerability to side effects, co-morbid conditions and our cultural environment, to name a few, to precise algorithms for care seem daunting.

So, why has it taken so long for medical science to unravel this heterogeneity and why should we be optimistic that personalized medicine will happen? In part, our current views stems from where we have previously focused our attention. “Bergkrankheit “(mountain sickness) was known in the 14th century as an affliction of metal ore miners in Europe. By the 20th century we knew this as lung cancer and attributed it to a variety of environmental exposures. In this century, we have further refined our description of this disease to specific aberrations in molecular pathways, which if not entirely causative, account for much of the disease biology.

By contrast, medicinal chemistry as a science started much later than clinical medicine and is now closing the gap between knowing precisely what causes an illness to precisely what to do about it to improve the outcome for individual patients. No doubt we have a long way to go, but the current pace of personalized medicines suggests that it is becoming everyday reality for many lung cancer patients.

This entry is reposted with permission from PhRMA’s blog, The Catalyst.

ASCO’s Annual Meeting this week highlighted some of the exciting advances that are emerging in the fight against cancer. PhRMA has joined with many other organizations in supporting a conference next week, “Turning the Tide Against Cancer Through Sustained Medical Innovation,” which is focused on the critical issue of how we sustain this progress in an era of increasing cost-cutting pressure. Conference participants will examine how we measure the value of new treatments and how we can promote high quality, patient-centered care.

The conference is being convened by the American Association of Cancer Research, the Personalized Medicine Coalition, and Feinstein Kean Healthcare. We sat down with each of the conference co-hosts about the event and progress in cancer care.

Conversation with Margaret Foti, Ph.D., M.D. (h.c.), CEO, American Association for Cancer Research

Q: In looking at where we want to go in progress against cancer, we sometimes lose sight of where we’ve come. Set the stage for us – how has scientific progress changed the outlook for patients against cancer in recent years?

Marge Foti: We have made tremendous progress against cancer. There are more than 12 million cancer survivors in America today and cancer mortality rates continue to decline. This progress is thanks to scientific discoveries that have revealed the underlying biology of a cancer cell and how the survive and grow in our bodies—knowledge that has given us a new understanding that cancer is not, in fact, a single disease but more than 200 diseases, each with unique causes and characteristics that require different treatments. New advanced technologies have improved our ability to turn this knowledge of how cancer works against cancer. We now are better able to prevent, detect and treat cancer.

Q: AACR put out a great report last year, the Cancer Progress Report, which describes many of the exciting advances being made in cancer research. What big trends do you expect we will hear about at the upcoming conference? What big challenges?

Marge Foti: Personalized medicine is more than just a buzz word; it is offering great promise to transform the outlook for many forms of cancer. We are truly entering an era when every patient’s tumor can be characterized at the molecular level, which is helping us redefine how we prevent, diagnose, and treat cancer. While this unprecedented progress is the direct result of fundamental discoveries from the past 40 years, further exploiting this knowledge to improve the outlook for cancer patients is going to require that our national policies keep pace with the continual advances that take place in science. For example, the recent approval of two new cancer medicines along with companion diagnostics is marking a new day of progress, but also is one that poses new challenges to researchers, companies, and regulators.

In addition, cancer’s complexity is astounding and exists at all levels–from populations, to individuals, to specific cancers, to the genes that underlie cancers. A major hurdle in the treatment of cancer is that that there is a high degree of variability in gene mutations—even within a single tumor in a single patient—and the variability increases with later stage disease.

Cancer research takes time and progress builds over time as new treatments are added on to one another in a step-wise fashion. Our growing scientific knowledge has the potential to change the face of drug development, to combine therapies in a rational way based on the mutations within an individual patient’s tumor. This is an enormous scientific and regulatory challenge, but the science is telling us this is the path forward.

Q: Why is it important to connect the science to policy?

Marge Foti: Continued progress is not a given. Advancing care for patients is an incredibly long, complex and expensive process. We need to provide continued support for basic research, and we need to preserve strong incentives for private sector investments in this process. Without a good understanding of the science, we risk taking policy approaches that will hamper the progress we so desperately need to make for current and future cancer patients.

In honor of the New England Journal of Medicine’s (NEJM’s) 200th Anniversary, the journal examined how medicine has evolved over the last two centuries, looking in particular at oncology diagnosis, prevention, and treatment. But while there has been tremendous progress in cancer, questions remain: Where do we go from here? And how do we get there in an era of immense fiscal discipline? These are questions that we plan to address on Tuesday at our conference, Turning the Tide Against Cancer Through Sustained Medical Innovation.

In a similar vein to what Siddhartha Mukherjee, M.D., a special guest speaker at the conference, lays out in his book The Emperor of All Maladies: A Biography of Cancer, the authors of the NEJM article “Two Hundred Years of Cancer Research” provide a timeline of major discoveries and advances in cancer research and care.

They show how each milestone is built on the ones that came before it and trace the evolution of cancer progress from the early efforts to control the disease through surgery, advances in radiation, chemotherapy, and the targeted therapies that are redefining cancer treatment today.

The underlying science that made these treatment advances possible takes years to translate into clinical benefits for patients, but the original investments pay off. Our understanding of the genetic basis of cancer became possible only after decades of work on the basic biology of DNA beginning in the 1940s and 50s, but it was not until after the sequencing of the human genome that researchers were able to begin to translate genetics knowledge into new medicines.

Genetic understandings of cancer have led to breakthrough new medicines such as Xalkori® (for non-small cell lung cancer) and Zelboraf® (for melanoma) and more targeted therapies are on the way. A new report issued by the Pharmaceutical Research and Manufacturers of America (PhRMA) found that there are 981 new medicines and vaccines for cancer in development today, many of which are likely to be personalized medicines.

Tomorrow’s progress in cancer therapies and treatment approaches depend on today’s policy makers recognizing the need for policies that holistically support cancer research and innovation. In advance of next week’s conference, a Discussion Paper “Sustaining Progress Against Cancer in an Era of Cost Containment” coalesces the views of the conference advisory committee and other leading cancer experts about new models for cancer innovation, how to define value in cancer care, and how policy can support continued progress against cancer.